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US12121669B2 - Assisted fluid drainage system - Google Patents

Assisted fluid drainage system
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US12121669B2
US12121669B2US17/373,568US202117373568AUS12121669B2US 12121669 B2US12121669 B2US 12121669B2US 202117373568 AUS202117373568 AUS 202117373568AUS 12121669 B2US12121669 B2US 12121669B2
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fluid
drainage
lumen
diameter
ejector pump
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US20220047842A1 (en
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Eric A. Rehm
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CR Bard Inc
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CR Bard Inc
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Abstract

Disclosed herein are systems and methods directed to an assisted fluid drainage system including one or more ejector vacuum pumps disposed in-line with the drainage tube. The one or more pumps can use a venturi effect vacuum pump to draw a fluid in and urge the fluid through the drainage tube to prevent the formation of dependent loops. Dependent loops can form within fluid drainage tubes when slack portions of tube create a positive incline. These dependent loops trap fluid and can create a retrograde flow, leading to various complications such as catheter associated urinary tract infections (“CAUTI”). Advantageously, the pumps can operate while the drainage lumen remains in fluid communication with the catheter. As such the pumps can operate continuously to prevent dependent loops from establishing.

Description

PRIORITY
This application claims the benefit of priority to U.S. Provisional Application No. 63/065,917, filed Aug. 14, 2020, which is incorporated by reference in its entirety into this application.
SUMMARY
Briefly summarized, systems and methods disclosed herein are directed to an assisted fluid drainage system including one or more vacuum pumps, e.g. ejector pump, disposed in-line with the drainage tube. The one or more vacuum pumps can use a venturi effect vacuum pump to draw a fluid in and urge the fluid through the drainage tube to prevent the formation of dependent loops. Dependent loops can form within fluid drainage tubes when slack portions of tube create a positive incline. These dependent loops trap fluid and can create a retrograde flow, leading to various complications. For example, urine pooling within a drainage tube can become a source of catheter associated urinary tract infection (“CAUTI”) causing agents such as bacteria, microbes, and the like. Hospital Acquired Infections (“HAI”), such as CAUTI, are detrimental to the patient, and also incur extra costs in treating these additional complications.
Disclosed herein is a fluid drainage system including, a drainage tube defining a lumen, configured to provide fluid communication between a catheter and a collection container, and including, a distal ejector pump disposed in-line with the lumen proximate the catheter, and a proximal ejector pump disposed in-line with the lumen proximate the collection container, wherein the distal ejector pump or the proximal ejector pump is configured to urge a fluid through drainage tube while the drainage tube remains in fluid communication with the catheter.
In some embodiments, the distal ejector pump or the proximal ejector pump includes a ring drive nozzle extending annularly about the lumen. The distal ejector pump or the proximal ejector pump includes an array of drive nozzles arranged in a ring-shaped formation extending annularly about the lumen. The distal ejector pump or the proximal ejector pump includes a converging section, a diffuser section, and a diverging section. A diameter of the diffuser section is less than a diameter of one of the converging section or the diverging section. The diverging section includes a stepped expansion portion. A drive nozzle provides a drive fluid at the stepped expansion portion. The distal ejector pump or the proximal ejector pump provides a vacuum influencing a portion of the lumen that is less than an entire length of the drainage tube. The distal ejector pump influences a fluid disposed in a first portion of the lumen and the proximal ejector pump influences a fluid disposed in a second portion of the lumen, different from the first portion of the lumen.
Also disclosed is a method of draining a fluid from a catheter to a collection container including, providing a drainage tube defining a lumen, providing fluid communication between the catheter and the collection container, and including a first ejector pump disposed proximate the catheter, and a second ejector pump disposed proximate the collection container, providing a drive fluid to one of the first ejector pump or the second ejector pump, entraining a drainage fluid disposed in a distal portion of the lumen, with the first ejector pump, to urge the drainage fluid from the distal portion to a proximal portion of the lumen, and entraining the drainage fluid disposed in the proximal portion of the lumen, with the second ejector pump, to urge the drainage fluid from the proximal portion to the collection container.
In some embodiments, the drainage tube remains in fluid communication with the catheter while one of the first ejector pump or the second ejector pump entrains the drainage fluid. The first ejector pump or the second ejector pump operates continually. The first ejector pump or the second ejector pump operates intermittently. The first ejector pump and the second ejector pump operates either simultaneously or sequentially. The drainage tube includes a sample port or an inlet vent disposed distally of the first ejector pump, the vent configured to allow a gas to enter the lumen. In some embodiments, the method further includes an outlet vent disposed proximally of the proximal pump configured to allow a gas to escape. The first ejector pump or the second ejector pump includes a ring drive nozzle extending annularly about the lumen. The first ejector pump or the second ejector pump includes a converging section, a diffuser section, and a diverging section. The diverging section includes a stepped expansion portion. A drive nozzle provides a drive fluid at the stepped expansion portion.
DRAWINGS
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
FIG.1 illustrates an exemplary fluid drainage system including a distal pump and a proximal pump, in accordance with embodiments disclosed herein.
FIG.2A illustrates a cross-sectional side view of a distal pump of the fluid drainage system ofFIG.1, in accordance with embodiments disclosed herein.
FIGS.2B-2C illustrates a cross-sectional axial view of embodiments of a drive nozzle, in accordance with embodiments disclosed herein.
FIG.3A illustrates a cross-sectional side view of a proximal pump of the fluid drainage system ofFIG.1, in accordance with embodiments disclosed herein.
FIGS.3B-3C illustrates a cross-sectional axial view of embodiments of a drive nozzle, in accordance with embodiments disclosed herein.
FIG.4A illustrates a columnized fluid disposed within a drainage tube, in accordance with embodiments disclosed herein.
FIG.4B illustrates a mixed fluid disposed within a drainage tube, in accordance with embodiments disclosed herein.
DESCRIPTION
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
In the following description, certain terminology is used to describe aspects of the invention. For example, in certain situations, the term “logic” is representative of hardware, firmware or software that is configured to perform one or more functions. As hardware, logic may include circuitry having data processing or storage functionality. Examples of such circuitry may include, but are not limited or restricted to a hardware processor (e.g., microprocessor with one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application specific integrated circuit “ASIC,” etc.), a semiconductor memory, or combinatorial elements.
Alternatively, logic may be software, such as executable code in the form of an executable application, an Application Programming Interface (API), a subroutine, a function, a procedure, an applet, a servlet, a routine, source code, object code, a shared library/dynamic load library, or one or more instructions. The software may be stored in any type of a suitable non-transitory storage medium, or transitory storage medium (e.g., electrical, optical, acoustical or other form of propagated signals such as carrier waves, infrared signals, or digital signals). Examples of non-transitory storage medium may include, but are not limited or restricted to a programmable circuit; semiconductor memory; non-persistent storage such as volatile memory (e.g., any type of random access memory “RAM”); or persistent storage such as non-volatile memory (e.g., read-only memory “ROM,” power-backed RAM, flash memory, phase-change memory, etc.), a solid-state drive, hard disk drive, an optical disc drive, or a portable memory device. As firmware, the executable code may be stored in persistent storage.
The term “computing device” should be construed as electronics with the data processing capability and/or a capability of connecting to any type of network, such as a public network (e.g., Internet), a private network (e.g., a wireless data telecommunication network, a local area network “LAN”, etc.), or a combination of networks. Examples of a computing device may include, but are not limited or restricted to, the following: a server, an endpoint device (e.g., a laptop, a smartphone, a tablet, a “wearable” device such as a smart watch, augmented or virtual reality viewer, or the like, a desktop computer, a netbook, a medical device, or any general-purpose or special-purpose, user-controlled electronic device), a mainframe, internet server, a router; or the like.
A “message” generally refers to information transmitted in one or more electrical signals that collectively represent electrically stored data in a prescribed format. Each message may be in the form of one or more packets, frames, HTTP-based transmissions, or any other series of bits having the prescribed format.
The term “computerized” generally represents that any corresponding operations are conducted by hardware in combination with software and/or firmware.
As shown inFIG.1, and to assist in the description of embodiments described herein, a longitudinal axis extends substantially parallel to an axial length of a catheter/drainage tube. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
FIG.1 shows an exemplary assisted fluid collection system (“system”)100, which generally includes acatheter110, a drainage tube (“tube”)120, and a collection container (“container”)130.Exemplary catheters110 include indwelling catheters, Foley catheters, balloon catheters, peritoneal drainage catheters, or the like, and are configured to be inserted into an orifice within the body of a patient to drain a fluid therefrom. Exemplary body fluids can include urine, blood, interstitial fluid, peritoneal fluid, saliva, mucus, or the like. In an embodiment, thecatheter110 can be inserted through the urethra and into a bladder of a patient. Thecatheter110 includes aneyelet114 that provides fluid communication with a lumen of thecatheter110, and is configured to drain a fluid, e.g. urine.
Thedrainage tube120 extends from a proximal end of thecatheter110 to acollection container130. Thedrainage tube120 defines adrainage lumen122 that provides fluid communication between thecatheter lumen112 and thecollection container130.
Thedrainage tube120 can be formed of rubber, plastic, polymer, silicone, or similar suitable material. Thecollection container130 can include a rigid container, a flexible collection bag, or similar suitable container for receiving a fluid, e.g. urine, drained from thecatheter110. In an embodiment, thecontainer130 includes adrainage outlet132 to allow the fluid to be emptied from thecollection container130. In an embodiment, thecontainer130 includes anoutlet vent134 configured to allow air or similar gas to be released from thecollection container130. In an embodiment, theoutlet vent134 can include a filter, valve, or similar structure configured to allow gas to escape from the container but to prevent a liquid from passing through theoutlet vent134.
In an embodiment, thedrainage tube120 can include one or more vacuum pumps, such as a first, distal vacuum pump (“distal pump”)200 disposed in-line with the lumen of thedrainage tube120 proximate a distal end of thetube120, and a second, proximal vacuum pump (“proximal pump”)300 disposed in-line with thelumen122 of thedrainage tube120 proximate a proximal end of thetube120. It will be appreciated that additional vacuum pumps disposed therebetween are also contemplated to fall within the scope of the present invention. In an embodiment, the one or more vacuum pumps, e.g. pumps200,300, can be identical. In an embodiment, the one or more vacuum pumps, e.g. pumps200,300, can differ in size, configuration, vacuum pump characteristics, flow resistance characteristics, combinations thereof, or the like.
Thedrainage tube120 can further include asample port124 or aninlet air vent126. Thesample port124 can include a cap, valve or similar structure configured to allow selective access to thedrainage tube lumen122 to sample a fluid disposed therein. Theinlet vent126 can include a cap, valve or similar structure configured to allow air or a gas to enter thedrainage lumen122 but to prevent air, gas, or fluid from escaping from thedrainage lumen122. In an embodiment, thesample port124 and theinlet vent126 can be separate structures. In an embodiment, thesample port124 and theinlet vent126 can be the same structure. In an embodiment, thedrainage tube120 can include one or more of thesample port124 or inlet vents126. As shown inFIG.1, thesample port124 and theinlet vent126 can be disposed proximate a distal end of thedrainage tube120 and can be disposed distally of thedistal pump200. However, it will be appreciated that one or more of the sample port(s)124 or the inlet vent(s)126 can be disposed at other positions along the length of the drainage tube, for example between thedistal pump200 and theproximal pump300, or proximal of theproximal pump300.
FIGS.2A-3C show further details of the one or more vacuum pumps disposed in-line with thedrainage tube120.
FIGS.2A-2C show details of afirst vacuum pump200 disposed proximate a distal end of thedrainage tube120. Thedistal pump200 can be an ejector pump that feeds apressurized drive fluid30 into adrainage lumen210 to entrain a fluid, e.g. adrainage fluid10, disposed within thedrainage lumen210. As used herein, thedrainage fluid10 can be a gas, liquid, or a mixed combination thereof, such as a vapor, or droplets of liquid mixed with gas. Thedistal pump200 can include ahousing202 formed of afirst housing piece204 and a second housing piece206. In an embodiment, thefirst housing piece204 is disposed distally of the second housing piece206. A distal surface of thefirst housing piece204 can engage a proximal surface the second housing piece206 to form thehousing202. Thefirst housing piece204 can be attached to the second housing piece206 using adhesive, bonding, welding, or the like. Further, one of thefirst housing piece204 or the second housing piece206 can include aprotrusion282, configured to engage arecess284 disposed on the opposing piece to align and secure thefirst housing piece204 with the second housing piece206. However, it will be appreciated that various numbers or configurations ofprotrusions282 and recesses284 are contemplated. Further, it will be appreciated that various attachment mechanisms including lugs, clips, snap-fit, interference fit, press fit engagements, or combinations thereof, are also contemplated to fall within the scope of the present invention. In an embodiment, thehousing202 can be formed as a single unitary piece by injection molding, 3D printing, or similar suitable means.
Thedistal vacuum pump200 can include adrainage lumen210 extending along a longitudinal axis from adrainage inlet212 disposed at a distal end to adrainage outlet214 disposed at a proximal end. Thedrainage lumen210 can define a substantially circular cross-sectional shape. However, it will be appreciated that other cross-sectional shapes are also contemplated including square, triangular, hexagonal or any closed curve, regular or irregular polygonal shapes. In an embodiment, the cross-sectional shape can define a radially symmetrical shape.
In an embodiment theinlet212 can be releasably coupled with a distal portion of thedrainage tube120. In an embodiment theinlet212 can be integrally formed with a distal portion of thedrainage tube120. In an embodiment thedrainage outlet214 can be releasably coupled with a proximal portion of thedrainage tube120. In an embodiment theoutlet214 can be integrally formed with a distal portion of thedrainage tube120. As such, thedrainage lumen210 of thedistal vacuum pump200 can be disposed in-line alumen122 of thedrainage tube120.
Thedrainage lumen210 of thedistal vacuum pump200 can include a convergingsection220, adiffuser section230, and a divergingsection240. The convergingsection220 can extend from thedrainage inlet212 to a distal end of thediffuser section230. Thediffuser section230 can extend from a proximal end of the convergingsection220 to a distal end of the divergingsection240. The divergingsection240 can extend from a proximal end of thediffuser section230 to adrainage outlet214.
Thedrainage lumen210 of the convergingsection220 can define a first diameter (d1) proximate thedrainage inlet212 and a second diameter (d2), less than the first diameter (d1) proximate thediffuser section230. In an embodiment, thedrainage lumen210 of the convergingsection220 can define a continuous change in diameter between the first diameter (d1) and second diameter (d2), i.e. defining a continuous, tapered, cone shape.
In an embodiment, thedrainage lumen210 of the convergingsection220 can define a discontinuous change in diameter between the first diameter (d1) and second diameter (d2). For example, as shown inFIG.2A, the convergingsection220 can include anaccumulation portion222 that defines a gradual reduction in diameter from the first diameter (d1), such that a wall of theaccumulation portion222 extends at a shallow angle of between 1° and 5°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated. In an embodiment, a wall of theaccumulation portion222 can extend parallel to a longitudinal axis.
The convergingsection220 can also include ashoulder portion224 wherein an angle of the wall of thedrainage lumen210 can vary between 5° and 20°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated. The convergingsection220 can also include anacceleration portion226 that defines a greater reduction in diameter over a given longitudinal distance, than theaccumulation portion222, such that a wall of thedrainage lumen210 extends at an angle of between 20° and 40°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated. It will be appreciated that embodiments of the convergingsection220 can include various numbers, orders, and configurations of one of theaccumulation portion222,shoulder portion224, or theacceleration portion226.
In an embodiment, thedrainage lumen210 of thediffuser section230 can define a substantially continuous diameter such that a diameter of thedrainage lumen210 at a distal end of thediffuser section230, e.g. second diameter (d2) is substantially the same as a diameter of thedrainage lumen210 at a proximal end of thediffuser section230, e.g. third diameter (d3). Worded differently, a wall of thedrainage lumen210 of thediffuser section230 can extend substantially parallel to the longitudinal axis.
In an embodiment, thedrainage lumen210 of thediffuser section230 can define a diverging diameter shape such that a diameter of thedrainage lumen210 at a distal end of thediffuser section230, e.g. second diameter (d2) is less than a diameter of thedrainage lumen210 at a proximal end of thediffuser section230, e.g. third diameter (d3). Worded differently, a wall of thedrainage lumen210 of thediffuser section230 can extend at an angle relative to the longitudinal axis.
In an embodiment, thedrainage lumen210 of thediffuser section230 can define a converging diameter shape such that a diameter of thedrainage lumen210 at a distal end of thediffuser section230, e.g. second diameter (d2) is greater than a diameter of thedrainage lumen210 at a proximal end of thediffuser section230, e.g. third diameter (d3). In an embodiment, thediffuser section230 can define a continuous change in diameter between the second diameter (d2) and the third diameter (d3). In an embodiment, thediffuser section230 can define a discontinuous change in diameter between the second diameter (d2) and the third diameter (d3).
Thedrainage lumen210 of the divergingsection240 can define a diverging diameter shape diverging from the third diameter (d3) disposed proximate the distal end of the divergingsection240, to a fourth diameter (d4) disposed proximate thedrainage outlet214, the fourth diameter (d4) being greater than the third diameter (d3).
In an embodiment, thedrainage lumen210 of the divergingsection240 can define a continuous change in diameter between the third diameter (d3) and the fourth diameter (d4), e.g. to define an inverse tapering, cone shape relative to the direction of flow through thedrainage lumen210. In an embodiment, thedrainage lumen210 of the divergingsection240 can define a discontinuous change in diameter between the third diameter (d3) and the fourth diameter (d4). For example, the divergingsection240 can include a steppedexpansion242 in diameter of thedrainage lumen210 wherein a portion of the wall of thedrainage lumen210 extends perpendicular to the longitudinal axis. Further, the divergingsection240 can include anexpansion portion244 wherein a portion of the wall of thedrainage lumen210 can extend at a shallow angle of between 1° and 5°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated. In an embodiment, a wall of theexpansion portion244 can extend parallel to the longitudinal axis. It will be appreciated that embodiments of the divergingsection240 can include various numbers, orders, and configurations of steppedportions242 orexpansion portion244. In an embodiment one or more transition edges between the convergingsection320,diffuser section330, divergingsection340, or portions thereof, can include a chamfered edge.
Thedistal vacuum pump200 can further include adrive nozzle260. In an embodiment, as shown inFIG.2B, thedrive nozzle260 can define a ring-shaped cross-section extending annularly about thediffuser section230, when viewed in cross-section to the longitudinal axis. In an embodiment, as shown inFIG.2C, thedrive nozzle260 can include an array of nozzles arranged in a ring shape extending annularly about thediffuser section230, when viewed in cross-section to the longitudinal axis.
Thedistal vacuum pump200 can include adrive fluid inlet262 that can provide apressurized drive fluid30 to aplenum264. Theplenum264 can provide thepressurized drive fluid30 to thedrive nozzle260. In an embodiment, thedrive fluid30 can include pressurized air, however, any suitable pressurized gas or liquid are also contemplated. In an embodiment, thedrive fluid30 can be provided by a separate line. In an embodiment, thedrainage tube120 can include a dual lumen, a first lumen can define thedrainage lumen122, a second lumen can provide apressurized drive fluid30 to one or more vacuum pumps, e.g. thedistal pump200 orproximal pump300.
In an exemplary method of use, adrive fluid30 is provided to thedrive fluid inlet262 and supplied through theplenum264 to thedrive nozzle260. Thedrive nozzle260 is designed to provide a drive jet into thedivergent section240 that entrains adrainage fluid10, e.g. a gas, liquid, or mixed combination thereof, disposed within thedrainage lumen210. More specifically, the jet ofdrive fluid30 is provided at a steppedportion242 of thedivergent section240 that substantially aligns with a transition between thediffuser section230 and thedivergent section240. Thedrive fluid30 entrains adrainage fluid10 disposed in thediffuser section230 that creates a low pressure in theconvergent section220, which draws adrainage fluid10 from thedrainage inlet212 proximally into thedrainage lumen210. Further, thedrive jet30 urges thedrainage fluid10 through thedivergent section240, through thedrainage outlet214 proximally into a proximal portion of thedrainage tube120.
Advantageously, the configuration of thedrainage lumen210 together with thedrive jet30 induces an amplifying effect, whereby a force of thepressurized drive fluid30 is less than a suction force applied to thedrainage fluid10 at thedrainage inlet212. Advantageously, thedistal vacuum pump200 can draw either acolumned drainage fluid10 or a mixed drainage fluid10 (e.g. liquid and gas mixture) from a distal portion of thedrainage tube120, disposed distally of thevacuum pump200, through thedrainage lumen210, and urge thedrainage fluid10 proximally through thedrainage tube120.
FIGS.3A-3B show further details of theproximal vacuum pump300. Theproximal pump300 can include ahousing302 formed of afirst housing piece304 and a second housing piece306. In an embodiment, thefirst housing piece304 is disposed distally of the second housing piece306. A distal surface of thefirst housing piece304 can engage a proximal surface the second housing piece306 to form thehousing302.
Thefirst housing piece304 can be attached to the second housing piece306 using adhesive, bonding, welding, or the like. Further, one of thefirst housing piece304 or the second housing piece306 can include aprotrusion382, configured to engage arecess384 disposed on the opposing piece to align and secure thefirst housing piece304 with the second housing piece306. However, it will be appreciated that various numbers or configurations ofprotrusions382 and recesses384 are contemplated. Further, it will be appreciated that various attachment mechanisms including lugs, clips, snap-fit, interference fit, press fit engagements, or combinations thereof, are also contemplated to fall within the scope of the present invention. In an embodiment, thehousing302 can be formed as a single unitary piece by injection molding, 3D printing, or similar suitable means.
Theproximal vacuum pump300 can generally include adrainage lumen310 extending along a longitudinal axis from adrainage inlet312 disposed at a distal end to adrainage outlet314 disposed at the proximal end. Thedrainage lumen310 can define a substantially circular cross-sectional shape. However, it will be appreciated that other cross-sectional shapes are also contemplated including square, triangular, hexagonal or any closed curve, regular or irregular polygonal shapes. In an embodiment, the cross-sectional shape can define a radially symmetrical shape.
In an embodiment theinlet312 can be releasably coupled with a distal portion of thedrainage tube120. In an embodiment theinlet312 can be integrally formed with a distal portion of thedrainage tube120. In an embodiment theoutlet314 can be releasably coupled with a proximal portion of thedrainage tube120. In an embodiment theoutlet314 can be integrally formed with a distal portion of thedrainage tube120. As such, thedrainage lumen310 of theproximal vacuum pump300 can be disposed in-line with alumen122 of thedrainage tube120.
Theproximal vacuum pump300 can include a convergingsection320, adiffuser section330, and a divergingsection340. The convergingsection320 can extend from thedrainage inlet312 to a distal end of thediffuser section330. Thediffuser section330 can extend from a proximal end of the convergingsection320 to a distal end of the divergingsection340. The divergingsection340 can extend from a proximal end of thediffuser section330 to adrainage outlet314.
Thedrainage lumen310 of the convergingsection320 can define a first diameter (d1) proximate thedrainage inlet312 and a second diameter (d2), less than the first diameter (d1) proximate thediffuser section330. In an embodiment, thedrainage lumen310 of the convergingsection320 can define a continuous change in diameter between the first diameter (d1) and second diameter (d2) i.e. defining a continuous, tapered, cone shape.
In an embodiment, thedrainage lumen310 of the convergingsection320 can define a discontinuous change in diameter between the first diameter (d1) and second diameter (d2). For example, as shown inFIG.3A, the convergingsection320 can include anaccumulation portion322 wherein a wall of theaccumulation portion322 extends substantially parallel to a longitudinal axis. In an embodiment, theaccumulation portion322 can define a gradual reduction in diameter from the first diameter (d1), such that a wall of theaccumulation portion322 extends at an angle of between 1° and 5°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated.
The convergingsection320 can also include a steppedportion324 wherein an angle of the wall of the convergingsection320 extends perpendicular relative to the longitudinal axis. The convergingsection320 can also include an acceleration portion326 that defines a greater reduction in diameter over a given longitudinal distance, than theaccumulation portion322, such that a wall of the acceleration portion326 extends at an angle of between 10° and 40°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated. It will be appreciated that embodiments of the convergingsection320 can include various numbers, orders, and configurations of one of theaccumulation portion322,shoulder portion324, or the acceleration portion326.
In an embodiment, thedrainage lumen310 of thediffuser section330 can define a substantially continuous diameter such that a diameter of thedrainage lumen310 at a distal end of thediffuser section330, e.g. second diameter (d2) is substantially the same as a diameter of thedrainage lumen310 at a proximal end of thediffuser section330, e.g. third diameter (d3). Worded differently, a wall of thedrainage lumen310 of thediffuser section330 can extend substantially parallel to the longitudinal axis.
In an embodiment, thedrainage lumen310 of thediffuser section330 can define a diverging diameter shape such that a diameter of thedrainage lumen310 at a distal end of thediffuser section330, e.g. second diameter (d2) is less than a diameter of thedrainage lumen310 at a proximal end of thediffuser section330, e.g. third diameter (d3). Worded differently, a wall of thedrainage lumen310 of thediffuser section330 can extend at an angle relative to the longitudinal axis.
In an embodiment, thedrainage lumen310 of thediffuser section330 can define a converging diameter shape such that a diameter of thedrainage lumen310 at a distal end of thediffuser section330, e.g. second diameter (d2) is greater than a diameter of thedrainage lumen310 at a proximal end of thediffuser section330, e.g. third diameter (d3). In an embodiment, thediffuser section330 can define a continuous change in diameter between the second diameter (d2) and the third diameter (d3). In an embodiment, thediffuser section330 can define a discontinuous change in diameter between the second diameter (d2) and the third diameter (d3).
Thedrainage lumen310 of the divergingsection340 can define a diverging diameter shape diverging from the third diameter (d3) disposed proximate the distal end of the divergingsection340, to a fourth diameter (d4) disposed proximate thedrainage outlet314, the fourth diameter (d4) being greater than the third diameter (d3).
In an embodiment, thedrainage lumen310 of the divergingsection340 can define a continuous change in diameter between the third diameter (d3) and the fourth diameter (d4) e.g. to define an inverse tapering, cone shape relative to the direction of flow through thedrainage lumen310. In an embodiment, thedrainage lumen310 of the divergingsection340 can define a discontinuous change in diameter between the third diameter (d3) and the fourth diameter (d4). For example, the divergingsection340 can include a steppedexpansion342 in diameter of thedrainage lumen310 wherein a portion of the wall of thedrainage lumen310 extends perpendicular to the longitudinal axis. Further, the divergingsection340 can include anexpansion portion344 wherein a portion of the wall of thedrainage lumen310 can extend at an angle of between 1° and 5°, relative to the longitudinal axis. However, greater or lesser angles are also contemplated. In an embodiment, a wall of theexpansion portion344 can extend substantially parallel to a longitudinal axis.
It will be appreciated that embodiments of the divergingsection340 can include various numbers, orders, and configurations of steppedportions342 orexpansion portion344. In an embodiment, one or more transition edges between the convergingsection320,diffuser section330, divergingsection340, or portions thereof, can include a chamfered edge.
Theproximal vacuum pump300 can further include adrive nozzle360. In an embodiment, as shown inFIG.3B, thedrive nozzle360 can define a ring shape extending annularly about thediffuser section330, when viewed in cross-section to the longitudinal axis. In an embodiment, as shown inFIG.3C, thedrive nozzle360 can include an array of nozzles arranged in a ring shape extending annularly about thediffuser section330, when viewed in cross-section to the longitudinal axis.
Theproximal vacuum pump300 can include adrive fluid inlet362 that can provide apressurized drive fluid30 to aplenum364. Theplenum364 can provide thepressurized drive fluid30 to thedrive nozzle360. In an embodiment, thedrive fluid30 can include pressurized air, however, any suitable pressurized gas or liquid are also contemplated.
In an embodiment, thedistal pump200 and theproximal pump300 can be identical. In an embodiment, thedistal pump200 and theproximal pump300 can be different, in either configuration and/or properties of the pump. For example, the pumps can differ in overall size, configuration of the drainage lumen profile, configuration of the drive nozzle/nozzle array, number of drive nozzles, drive fluid inlet resistance, combinations thereof, or the like.
In an embodiment, one of the distal orproximal pumps200,300, can be tuned differently from the other, such as providing a different vacuum force or providing greater or lesser volume movement, or the like. For example, a larger overall pump can provide a greater movement of volume of fluid. By contrast, an overall smaller pump, including identical proportions to the larger pump, can achieve a harder vacuum (lower absolute pressure). Further, individual pump characteristics can be further modified by modifying a volume or pressure ofdrive fluid30 supplied thereto. As such each of theproximal pump200 and thedistal pump300 can be tuned to provide specific pump characteristics for their respective location along thedrainage tube120.
In an exemplary method of use, adrive fluid30 is provided to thedrive fluid inlet362 and supplied through theplenum364 to thedrive nozzle360. Thedrive nozzle360 provides a drive jet into thedivergent section340 that entrains adrainage fluid10, e.g. a gas, liquid, or mixed combination thereof, disposed in thedrainage lumen310. More specifically, the jet ofdrive fluid30 is provided at a steppedportion342 of thedivergent section240 that substantially aligns with a transition between thediffuser section330 and thedivergent section240. Thedrive fluid30 entrains adrainage fluid10 disposed in thediffuser section330 that creates a low pressure in theconvergent section320, which draws adrainage fluid10 from thedrainage inlet312, proximally through thedrainage lumen310. Further, the drive jet urges thedrainage fluid10 through thedivergent section340, proximally into a proximal portion of thedrainage tube120.
Advantageously, the configuration of thedrainage lumen310 together with thedrive jet30 induces an amplifying effect, whereby a force of thepressurized drive fluid30 is less than a suction force applied to thedrainage fluid10 at thedrainage inlet312. Advantageously, theproximal vacuum pump300 can draw either acolumned drainage fluid10 or a mixed drainage fluid10 (e.g. liquid and gas mixture) from a portion of thedrainage tube120, disposed distally of theproximal vacuum pump300, through thedrainage lumen310, and urge thedrainage fluid10 proximally through thedrainage tube120 and into the collection container.
Advantageously, the assistedfluid drainage system100 including the ejector pumps200,300 can prevent the formation of dependent loops within thedrainage lumen122.
Advantageously, thesystem100 can operate under lower pressure conditions and does not require a valve to separate fluid communication between thecatheter110 and thedrainage tube120 during operation. Thecatheter110, including columnized fluid disposed within thecatheter lumen112, can provide a greater flow resistance than a flow resistance of theinlet vent126. As such thedistal pump200 creates a vacuum that entrains a fluid, which includes liquid disposed within thedrainage lumen122 and air from theinlet vent126. The vacuum is not communicated throughcatheter110 to the patient. Instead fluid from thecatheter110 can transfer (e.g. by gravity, diffusion, etc.) to thedrainage lumen122 before being entrained by thedistal pump200. Since thedistal pump200 operating at the lower pressure is unable to urge the fluid through the proximal portion of thedrainage lumen122, subsequent pumps disposed along the drainage lumen, e.g.proximal pump300, can continue to urge the fluid through thedrainage tube120 to thecollection container130.
In an embodiment, thevacuum pumps200,300 can work in conjunction to urge adrainage fluid10 through thedrainage tube120. The influence of a pump on a fluid within a pipe can be limited by a number of factors, e.g. fluid temperature, state, gas or fluid mix, incline, etc. As such the influence of a pump can be limited to a given longitudinal length. To overcome these limitations, a greater vacuum force can be applied by the pump to move a fluid from thecatheter110, through thedrainage tube120, and into thecollection container130. However, such a force can cause trauma to a patient, as such acatheter110 must be disconnected from thedrainage tube120, e.g. by shutting a valve or the like, before the pump can clear the drainage line.
Embodiments disclosed herein teach one ormore pumps200,300 disposed along thedrainage tube120. Thepumps200,300 can operate at lower forces to allow the pumps to operate while thedrainage tube120 remains in fluid communication with thecatheter110. While thepumps200,300 operating at lower forces, have a shorter length of influence along the drainage lumen, thepumps200,300 can work in conjunction to influence the entire length of thedrainage tube120. For example, as shown inFIG.4A alarger pump400 providing a greater force ofdrive fluid30A can have a greater influence on thedrainage fluid10, i.e. influencing thedrainage fluid10 over a greater longitudinal distance oftube120, distance (x). This distance can be distal (upstream) of the pump and require greater suction or proximal (downstream) and require greater pushing.
As shown inFIG.4B, where a lesser force ofdriver fluid30B is applied, the pump has a lesser influence on thedrainage fluid10, i.e. influencingdrainage fluid10 over a shorter longitudinal distance oftube120, distance (y). However, two or more pumps, e.g. pumps200,300, can operate at the lesserdriver fluid force30A and work in conjunction to influence the same distance (where x=2y) ofdrainage tube120.
Further still a difference between acolumnized drainage fluid10A i.e. adrainage fluid10 that fills the drainage lumen, and amixed drainage fluid10B, i.e. a mix gas and liquid can further affect the influence length of a pump. For example,FIG.4A shows acolumnized drainage fluid10A along a distance (x). Should this be a mixed drainage fluid (e.g.FIG.4B) a still greater force drive fluid30 would be required to influence the same distance (x).
As noted, high pump forces can have a detrimental effect on a patient should thecatheter110 remain in fluid communication with the drainage tube when a sufficientdriver fluid force30 is applied to asingle pump400 to urge thedrainage fluid10 along an entire length of thedrainage tube120. As such, thecatheter110 must be fluidly disconnected, e.g. by shutting a valve, before such a pump can operate. By contrast, embodiments disclosed herein disclose two or more pumps operating at a lowerdriver fluid pressure30 to urge a drainage fluid through a portion of thedrainage lumen122. An adjacent pump can then be configured to urge thedrainage fluid10 through an adjacent portion ofdrainage lumen122.
Advantageously, embodiments described herein can operate to urge adrainage fluid10 through thedrainage lumen122 while thecatheter110 remains in fluid communication with thedrainage tube120. This allows thepumps200,300 to operate continuously while thecatheter110 is in place, without requiring coordinated closing and opening of valves or starting/stopping a pumps. As such, thesystem100 requires a simplified operation and manufacture, reducing associated costs.
As noted, a number of variables can affect the influence distance of a pump. In an embodiment, thepumps200,300 can be tuned such that adjacent influence distances (y) overlap undermixed drainage fluid10B conditions. If parameters of the drainage fluid change such that adjacent influence distances (y) do not overlap thendrainage fluid10 can potentially pool betweenpumps200,300. However, pooledfluid10 provides a columnized fluid10 that can cause the influence distance (y) to increase. As such thesystem100 and pumps200,300 can be tuned to self-regulate.
In an embodiment, the one ormore vacuum pumps200,300 can operate intermittently. In an embodiment, thesystem100 can include acontroller150 configured to control operation of one ormore vacuum pumps200,300. The controller include logic configured to operate one ormore vacuum pumps200,300 continuously, intermittently, concurrently, sequentially, alternately, or combinations thereof. Thecontroller150 operate thepumps200,300 concurrently to move thedrainage fluid10 through thedrainage tube120. In an embodiment, the one ormore pumps200,300 can be operated sequentially or alternately, to move a fluid10 through thedrainage tube120 in a “wave-like” manner.
In an embodiment, thecontroller150 can operate thepumps200,300 in response to a trigger. For example, thecontroller150 can trigger operation of the one ormore pumps200,300 in response to a given time interval elapsing, in response to an input such as the presence of liquid or an increase in fluid pressure within the drainage lumen, or combinations thereof. In an embodiment, thecontroller150 can be communicatively coupled with anetwork160, or similar external computing device such as an electronic health records system, intranet, mobile device, centralized or decentralized network or the like. This can allow a user to operate thecontroller150 remotely, or receive information about thesystem100.
Advantageously, the configuration of thepumps200,300 does not inhibit fluid flow throughdrainage tubes120 even when the pumps are not operating. This allows thedrainage system100 to function as a gravity driven system when the pumps are not operating increasing power efficiency of thesystem100. In an embodiment, atmospheric gas (air)20 can be provided to thesystem100 by way of theinlet vent124. Thisatmospheric gas20 can be mixed with thedrainage fluid10 and drawn through thedrainage tube120 into thecontainer130. The fluid10 can then be collected in thecontainer130 and excess gas can be vented from thesystem100 by way ofoutlet vent134. Advantageously, the one or more ejector pumps200,300 require no moving parts which can minimize maintenance costs and simplify manufacturing, along with associated cost savings. Further, the one ormore pumps200,300 can operate highly efficiently where a given force (f) of pressurized drive fluid produces a greater force (>f) of vacuum pressure.
While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims (5)

What is claimed is:
1. A fluid drainage system, comprising:
a catheter configured to drain a fluid from a patient;
a collection container configured to remain external to the patient; and
a drainage tube configured to remain external to the patient and defining a lumen, configured to provide fluid communication between the catheter and the collection container, and including:
a distal ejector pump disposed in-line with the lumen proximate the catheter; and
a proximal ejector pump disposed in-line with the lumen proximate the collection container,
wherein the distal ejector pump or the proximal ejector pump is configured to urge the fluid through the drainage tube while the drainage tube remains in fluid communication with the catheter,
wherein the distal ejector pump or the proximal ejector pump includes a converging section, a diffuser section, and a diverging section,
wherein a diameter of the diffuser section is less than a diameter of one of the converging section or the diverging section,
wherein the diverging section includes a stepped expansion portion, and
wherein a drive nozzle provides a drive fluid at the stepped expansion portion.
2. The fluid drainage system according toclaim 1, wherein the distal ejector pump or the proximal ejector pump includes a ring drive nozzle extending annularly about the lumen.
3. The fluid drainage system according toclaim 1, wherein the distal ejector pump or the proximal ejector pump includes an array of drive nozzles arranged in a ring-shaped formation extending annularly about the lumen.
4. The fluid drainage system according toclaim 1, wherein the distal ejector pump or the proximal ejector pump provides a vacuum influencing a portion of the lumen that is less than an entire length of the drainage tube.
5. The fluid drainage system according toclaim 4, wherein the distal ejector pump influences a first fluid disposed in a first portion of the lumen and the proximal ejector pump influences a second fluid disposed in a second portion of the lumen, different from the first portion of the lumen.
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